Navigation Links
Clinical Data Demonstrates 5-Year Efficacy and Safety of Aquamid(R) in Facial Augmentation
Date:5/5/2008

5-year European Clinical Study shows more than 90% Patient and Physician

Satisfaction

COPENHAGEN, Denmark, May 5 /PRNewswire/ -- Contura International A/S today announced that 5-year clinical data for its soft volume filler Aquamid(R) was presented at the annual meeting for the American Society of Aesthetic Plastic Surgery (ASAPS) in San Diego. Aquamid(R) is used to rejuvenate or contour the face, either by restoring lost volume or by adding extra volume where needed. Contura is currently conducting a multicenter, comparative clinical trial of Aquamid(R) in the United States.

The 5-year study presented at the ASAPS meeting is a multicenter, prospective study of safety and long-term aesthetic results of Aquamid(R) injections for facial soft tissue augmentation and facial contouring. A total of 116 patients attended the clinics for follow-up five years after their first Aquamid(R) injection. The aesthetic outcome of injections with the Aquamid(R) hydrogel showed that 96% of the 116 patients evaluated after five years had "very good" or "good" aesthetic results according to the physician investigators and 92% of the patients were "very satisfied" or "satisfied". The safety data in the trial showed that injection of Aquamid(R) over a period of 5 years was safe with few and no unexpected adverse events. The 5-year results are consistent with the data from the 1-year, 2-year and 3- to 4-year follow-up visits.

"We are excited that our European 5-year clinical data demonstrates the long-term efficacy and safety of Aquamid(R). Aquamid(R) is well positioned to meet the global consumer needs for long-lasting aesthetic treatments to restore facial volume. In 2008 we expect to complete the 12-month follow-up in our US clinical trial and look forward to submitting the data to the FDA for review," said Michael Peytz, Chief Executive Officer.

Produced using Contura's patented hydrogel technology, Aquamid(R) is composed of 97.5% sterile water and 2.5% cross-linked polyacrylamide. The Aquamid(R) hydrogel is homogeneous: it contains no microparticles; hence its filling effect is due solely to the injected volume. Unlike particle-based fillers, the hydrogel does not rely on an intended foreign body reaction to achieve the desired augmentation. Therefore, the filling effect is immediate and predictable. Moreover, the hydrogel does not cause tissue hardening or fibrosis. No skin test is needed before treatment.

The hydrogel integrates completely into the tissue and does not migrate from the injection site. It stays soft, feels like a natural part of the tissue and follows tissue movements. Because the hydrogel does not degrade over time, it provides augmentation that lasts for years.

Aquamid(R) is available in 40 countries worldwide and is under clinical investigation in the United States. Aquamid is being studied in a double-blind, randomized, multi-center, 2-arm parallel study involving 315 patients in 13 centers comparing the effectiveness of Aquamid(R) and Restylane(R) for the aesthetic treatment of facial wrinkles/folds. Data from this trial will support a PMA application with the FDA.

About Aquamid(R)

Aquamid(R) is a soft volume filler that gives a natural look and feel. Produced using Contura's patented hydrogel technology, Aquamid(R) is composed of 97.5% sterile water and 2.5% cross-linked polyacrylamide. Aquamid(R) was approved in Europe in 2001 and is available in 40 countries worldwide. Over 300,000 Aquamid(R) injections have been performed to date. It is currently under clinical investigation in the U.S. for the aesthetic treatment of facial wrinkles/folds. Aquamid(R) is not approved for sale in the United States.

About Contura

Contura is a medical technology company based in Denmark that develops and commercializes soft tissue fillers. Contura's products -- Aquamid(R) for facial contouring and Bulkamid(R) for the treatment of female urinary incontinence -- are manufactured using the company's patented polyacrylamide hydrogel technology. Aquamid(R) is sold through a network of local distributors in 40 countries. Ethicon Inc., a Johnson & Johnson company, holds the exclusive worldwide distribution rights for Bulkamid and has started to sell the product in Europe. Clinical trials evaluating Aquamid(R) and Bulkamid(R) are ongoing in the United States. Data from these trials will be used to support PMA applications for these products. Contura's products are developed, manufactured and tested in Denmark in compliance with the European regulatory requirements for medical devices.
http://www.contura.com

http://www.aquamid.com

Media Contact:

Contura

Michael Peytz

+45 40592021

mjp@contura.com

Ruder Finn

Aaron Estrada

+1 212.715.1568

estradaa@ruderfinn.com


'/>"/>
SOURCE Contura
Copyright©2008 PR Newswire.
All rights reserved

Related medicine technology :

1. N30 Pharma Announces Completion of Phase 1 Clinical Studies With N30-201
2. Senetek PLC Announces Positive Results from Pyratine-6(TM) Clinical Trial in Patients with Acne Rosacea
3. Volcano Announces Participation in SATURN Clinical Trial Sponsored by AstraZeneca
4. Alexza Pharmaceuticals to Present AZ-004 Phase 2a Clinical Data at the American Psychiatric Association Annual Meeting
5. Proteolix Initiates Phase 2 Clinical Trial of Carfilzomib in Patients With Relapsed Solid Tumors
6. Clinical Impact of OrbusNeichs Genous(TM) Bio-engineered R stent(TM) is Subject of Symposium at 16th Annual Scientific Congress of Hong Kong College of Cardiology
7. ISTA Pharmaceuticals Announces New Phase III Clinical Findings to Support Bepreve NDA Filing
8. Phosphagenics Reports Positive Pre-clinical Results for Targeted Delivery of Lidocaine
9. Alexza Completes Enrollment in Phase 2a Clinical Trial With AZ-002 (Staccato(R) Alprazolam) in Panic Disorder Patients
10. Innocoll Announces Dosing of First Patient in US Phase 2 Clinical Trial to Investigate CollaRx(R) GENTAMICIN TOPICAL for the Prevention of Diabetic Foot Infections
11. Quantum Immunologics, Inc. and the South Alabama Medical Science Foundation Announce an Early Clinical Evaluation of a Novel Immuno-therapeutic Vaccine for Treating Advanced Human Breast Carcinomas
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/10/2017)... -- NDS received FDA 510(k) clearance in May 2017 for its highly ... designed for endoscopy environments. An innovative secondary monitor solution, ZeroWire ... support the improvement of patient outcomes, procedural efficiency, and the lowering ... ... ...
(Date:10/4/2017)... 4, 2017  South Korean-based healthcare product Development Company ... "cprCUBE" on Kickstarter. The device will educate the user ... with better efficiency compared to the dated and pricey ... on efficacy of the compression for a more informed ... goal to raise $5,000. ...
(Date:10/2/2017)... 2017  Eli Lilly and Company (NYSE: ... third quarter of 2017 on Tuesday, October 24, 2017. ... day with the investment community and media to further ... call will begin at 9 a.m. Eastern time. Investors, ... webcast of the conference call through a link that ...
Breaking Medicine Technology:
(Date:10/13/2017)... (PRWEB) , ... October 13, 2017 , ... Apple ... care services, staged a mock evacuation of the facility as part of a disaster ... Fire Department, Echo Hose EMS and Shelton City Emergency Manager, as well as the ...
(Date:10/13/2017)... , ... October 13, 2017 , ... Global Healthcare Management’s ... Alexandria Park in Milford, NJ. This free event, sponsored by Global Healthcare Management’s ... The fun run is geared towards children of all ages; it is a ...
(Date:10/13/2017)... ... October 13, 2017 , ... “The Journey: From the ... danger possible to save lost souls in the Philippines. “The Journey: From the Mountains ... a dedicated teacher of the Bible. She has taught all ages and currently teaches ...
(Date:10/12/2017)... ... October 12, 2017 , ... Planet Fitness, one of the largest and ... plans to open a flagship location in Covington, LA at 401 N. U.S. Highway ... store next to Office Depot in the Holiday Square shopping center. Its location allows ...
(Date:10/12/2017)... ... 2017 , ... Asante, a nationally recognized health system in ... existing home health joint venture through an agreement, effective October 1, 2017, to ... home health company with Asante, delivering clinically integrated care, for the past eight ...
Breaking Medicine News(10 mins):